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Clinical Trial of TQB2618 Injection Combined With TQB2450 Injection in Patients With Advanced Solid Tumors

NCT05645315 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 127

Last updated 2022-12-09

No results posted yet for this study

Summary

This project is a phase Ib clinical trial study evaluating the efficacy and safety of TQB2618 injection combined with TQB2450 injection in patients with advanced solid tumors, the trial plan to enroll 127 subjects, the trial design is a phase I.b dose exploration and cohort expansion clinical study, aiming to evaluate the safety and efficacy of TQB2618 injection combined with TQB2450 injection in patients with advanced malignant solid tumors, and to evaluate TQB2618 injection, Pharmacokinetic characteristics, receptor occupancy and immunogenicity characteristics of TQB2450 injection; Biomarker studies related to the mechanism of action, safety and/or pathological mechanism of efficacy have dose-limiting toxicity (DLT) in Phase I, recommended dose in Phase II (RP2D), and objective response rate (ORR) in Phase II as the primary endpoints.

Conditions

  • Advanced Solid Tumor

Interventions

DRUG

TQB2618 injection and TQB2450 injection

TQB2618 is a TIM-3 receptor monoclonal antibody; TQB2450 is a new sequence of innovative anti-PD-L1 fully humanized monoclonal antibody;

Sponsors & Collaborators

  • Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-28
Primary Completion
2023-12-31
Completion
2024-06-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05645315 on ClinicalTrials.gov